drugset / Trial / NCT01437748
Closing Volume Interpretation and Bronchodilators Effect
RandomizedParallel-groupTriple-blindTreatment
Summary
* The gold standard measures to evaluate small airways (SAW) "in vivo" is not well understood * Two tests are today used to measure SAW but real results concordance is not clear * These problems have a small evidence * Data about real effect of bronchodilators on SAW (eg Tiotropium and Indacaterol) has never been studied * Only an acute bronchodilators effect, after one hour of drugs inhalation, will be evaluated * The time frame of study evaluations per patient will be of three hours: one hour for basal test; one hour rest after drug administration; one hour for post bronchodilators test * All enrolled subjects will be outpatients and will be evaluated after 24 hours of inhalatory drugs washout
Timeline
- Start
- 2011-08
- Primary completion
- 2014-09
- Completion
- 2014-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Indacaterol | Other / unclassified | 300 ug | Inhaled |
| Comparator | Tiotropium | Other / unclassified | 18 ug | Inhaled |